BETAGAN Eye drops, solution Ref.[9460] Active ingredients: Levobunolol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Allergan Limited, Marlow International, The Parkway, Marlow, Buckinghamshire, SL7 1YL, United Kingdom

Therapeutic indications

Reduction of intraocular pressure in chronic open-angle glaucoma and ocular hypertension.

Posology and method of administration

Posology

Adults (including the elderly)

The recommended adult dose is one drop of Betagan once or twice daily in the affected eye(s). Discard product after use.

Paediatric Population

Betagan is not recommended for use in children due to lack of safety and efficacy data.

Intraocular pressure should be measured approximately four weeks after starting treatment with Betagan as a return to normal ocular pressure can take a few weeks.

Method of administration

Topical into the conjunctival sac.

When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity.

Overdose

There are no data available on human overdosage with Betagan which is unlikely to occur via the ocular route. Should accidental ocular overdosage occur, flush the eye(s) with water or normal saline. If accidentally ingested, systemic symptoms may result and efforts to decrease further absorption may be appropriate. The symptoms associated with systemic overdosage are most likely to be bradycardia, hypotension, bronchospasm and cardiac failure. Therapy for overdosage of a beta-adrenergic agent should be instituted, such as intravenous administration of atropine sulfate 0.25 to 2 mg to induce vagal blockade. Conventional therapy for hypotension, bronchospasm, heart block and cardiac failure may be necessary.

Shelf life

18 months.

The eye drop solution should be used immediately after opening. Any unused solution should be discarded.

Special precautions for storage

Do not store above 25°C.

Keep the container in the outer carton in order to protect from light.

Nature and contents of container

Low density polyethylene (LDPE) blow-fill-seal unit dose container (0.9 ml volume) filled with 0.4 ml solution.

Unit dose containers are packaged into a foil covered pouch (2 strips of 5 containers per pouch).

Pouches are packaged into cartons such that each carton contains 30 or 60 unit dose containers.

Special precautions for disposal and other handling

Ensure that the single dose container is intact before use. Discard any unused solution (i.e. once opened do not re-use container for subsequent doses).

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